Upcoming 510(k) Improvements: FDA’s Tall Order

February 9th, 2011
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On January 19, the FDA’s Center for Devices and Radiological Health (CDRH) announced its action plan to address deficiencies of the 510(k) program. As the program exists today, some have argued that there’s a lack of clarity, efficiency and speed in the process. With that in mind, there’s been a push by industry, patient advocates and other critical stakeholders for significant change. Needless to say, the FDA has a tough balancing act to perform in this space.
For context, here’s a current definition of the 510(k) program from the FDA website:
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.”
In the past, the process associated with this program has created delays for companies to market their devices while at the same time it has protected the public from devices that perhaps were not quite ready to market.
According to a statement made by Jeffrey Shuren, Director of the CDRH, the FDA’s action plan is expected to create a transparent pathway through the 510(k) process to build “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.”
Some history behind the changes – in 2009, two committees were established to address the concerns expressed by industry, consumers, and healthcare providers about the impediments to the 510(k) program.  Namely, some stakeholders criticized the 510(k) program for being unpredictable, inconsistent, and opaque. As a result, some argued, medical device developers have begun to look outside of the U.S. to further develop and market their device in “better” regulatory markets.
The two committees established in 2009 are the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making.  In addition, the Institute of Medicine is also independently reviewing the 510(k) program and making recommendations.
The general public also had the opportunity to provide input into the recommendations, either in writing or through public meetings.  Consumers, healthcare professionals, patient advocates, industry, third party payors, venture capitalists, academicians, legal counsel, and other stakeholders were among the groups that provided comments to the FDA.
After receiving feedback from the public, the working groups made more than 50 recommendations for improvement of the 510(k) program. From the larger list of recommendations, 25 actions were developed into the action plan.
In my opinion, some of the most significant action plan recommendations include:


  • Streamlining the de novo process
  • Clarifying when to provide clinical data
  • Clarifying and consolidating the concepts of “indication for use” and “intended use”
  • Providing supplemental guidance on pre-IDE meetings and the 510(k) process
  • Creating a network of experts to review new medical device technologies

The agency has a tall order to fill and needs to make changes that will provide a scientifically based, efficient, and expeditious program to bring new devices and tests to market while at the same time assuring consumers and patients who use those devices that they are safe, effective, and economical.
What is your reaction to the FDA’s action plan? Have the right steps been addressed? What is missing? Share your thoughts here.
Update: Yesterday, the FDA announced that it would be reviewing cutting-edge medical devices through its newly proposed “Innovative Pathway,” a program intended to accelerate the time it usually takes to review truly innovative new devices. Only a few devices will be reviewed per year due to limited resources at the FDA. The program is subject to public comment at a meeting set up for March 15, 2011.
However, the Agency is still faced with the fact that the majority of medical devices are innovative but they may not be revolutionizing in terms of changing patient care — a current feature of the proposed pathway. Thus, most devices reviewed by the Agency would not go through the Innovative Pathway as currently defined.
We’ll continue to watch this unfold and to keep you updated!

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About the Author:

I have 20 years experience in clinical research, including leading diagnostic and pharmaceutical clinical studies in disease areas ranging from cancer to infectious disease to cardiology, diabetes, and autoimmune disorders. Send me an email.